Z-0997-2020 Class II Terminated
FDA device recall Z-0997-2020 was initiated by Roche Diabetes Care, Inc. on December 11, 2019 and is designated Class II. Reason for recall: Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions The recall status is terminated (terminated July 8, 2022). Affected quantity: 82,332 vials.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- July 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82,332 vials
Product Description
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Reason for Recall
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Distribution Pattern
Nationwide: Foreign: Austalia, India
Code Information
Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1